Active surveillance for low‐risk non‐muscle‐invasive bladder cancer: mid‐term results from the Bladder cancer Italian Active Surveillance (BIAS) project

Objective To report the oncological safety and the risk of progression for patients with non‐muscle‐invasive bladder cancer (NMIBC) included in an active surveillance (AS) programme after the diagnosis of recurrence. Patients and methods This is a prospective study enrolling patients with history of pathologically confirmed low grade pTa–pT1a NMIBC and diagnosed with a tumour recurrence. Inclusion criteria consisted of negative urine cytology, presence of ≤5 lesions with a diameter of ≤10 mm, absence of carcinoma in situ (CIS) or persistent gross haematuria. The primary outcome of interest was adherence to AS. Need to proceed with treatment was defined as progression in number/dimension/positive cytology/symptoms (gross haematuria persistent) or any further intervention (resection or electro‐fulguration). Finally, we assessed the up‐grading and up‐staging when transurethral resection of bladder tumour was performed. Results The study population consisted of 55 patients with a previous diagnosis of NMIBC (70 AS events) prospectively recruited since 2008. The mean patient age was 69.8 years. The median follow‐up was 53 months. The median time patients remained under AS was 12.5 months. There was disease progression in 28 patients (51%). No patient progressed to muscle‐invasive disease. In all, 15 patients (27.3%) had an increase in the number and/or size of the tumour, nine (16.4%) had haematuria, and four (7.3%) had a positive cytology. Only five (9%) patients in the whole series progressed to a high‐grade tumour (Grade 3) or presented with associated CIS. The overall adherence to the follow‐up schedule was 95%. Conclusion Our data show that an AS protocol for NMIBC could be a reasonable option in a select group of patients with small, recurrent cancers.